Prescribing Information

Dutoprol (metoprolol succinate extended release/hydrochlorothiazide) is used to treat hypertension, to lower blood pressure. Metoprolol is a beta1-selective (cardioselective) adrenoceptor-blocking agent, and hydrochlorothiazide is a diuretic. Common side effects include inflammation of the nose and throat, fatigue, dizziness, back pain, and nausea.

Dosing of Dutoprol is individualized considering baseline and target blood pressure and any experience with the individual drugs. The usual initial dose of metoprolol succinate extended release is 25 to 100 mg daily in a single dose. Hydrochlorothiazide is effective in doses of 12.5 mg to 50 mg once daily. Dutoprol may interact with cisapride, dofetilide, fingolimod, lithium, lumefantrine, quinidine, propafenone, SSRI antidepressants, St. John's wort, cough-and-cold products, diet aids, or NSAIDs. Tell your doctor all medications and supplements you use. During pregnancy, Dutoprol should be used only if prescribed. A small amount of metoprolol passes into breast milk. Thiazides pass into breast milk. Consult your doctor before breastfeeding.

Our Dutoprol (metoprolol succinate extended release/hydrochlorothiazide) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

SIDE EFFECTS

Clinical Trials Experience

Because clinical trials are conducted under widely
varying conditions, adverse reaction rates observed in the clinical trials of a
drug cannot be directly compared to rates in the clinical trials of another
drug and may not reflect the rates observed in practice. The adverse reaction
information from clinical trials does, however, provide a basis for identifying
the adverse events that appear to be related to drug use and for approximating
rates.

Metoprolol Succinate Extended Release/Hydrochlorothiazide

The metoprolol succinate extended release and
hydrochlorothiazide combination was evaluated for safety in 891 patients with
hypertension in clinical trials. In a randomized, double-blind,
placebo-controlled, factorial trial (Study 1), 843 patients were treated with
various combinations of metoprolol succinate (doses of 25 to 200 mg) and
hydrochlorothiazide (doses of 6.25 to 25 mg) [seeClinical Studies].
Adverse events which occurred more than 1% more frequently in patients treated
with DUTOPROL than placebo were: nasopharyngitis (3.4% vs 1.3%) and fatigue
(2.6% vs 0.7%).

The adverse reactions of metoprolol succinate extended
release are a mixture of dose-dependent phenomena (primarily bradycardia and
fatigue) and those of hydrochlorothiazide are a mixture of dose-dependent
(primarily hypokalemia) and dose independent phenomena (e.g., pancreatitis),
the former much more common than the latter. Therapy with DUTOPROL will be
associated with both sets of dose independent reactions.

Laboratory Abnormalities

Liver Enzyme Tests-Increases in liver enzymes or serum
bilirubin.

Post-Marketing Experience

The following adverse reactions have been identified
during post-approval use of DUTOPROL, metoprolol succinate extended release,
and/or hydrochlorothiazide. Because these reactions are reported voluntarily
from a population of uncertain size, it is not always possible to estimate
their frequency reliably or establish a causal relationship to drug exposure.

Metoprolol

The following adverse reactions have been reported for
immediate release metoprolol tartrate. Most adverse reactions have been mild
and transient.